Catheter collection and drainage device and system

ABSTRACT

A urine collection and drainage device and system adapted to facilitate drainage for patients to that prefer to stay standing during drainage and avoid removal of clothing near the collection bag. A collection vessel is designed to be secured to a user&#39;s waist and leg and allows for quick drainage with low initial compression. Drainage can also be accomplished for handicapped patients that have challenges getting out of bed or a wheelchair.

CLAIM OF PRIORITY TO INTERNATIONAL APPLICATION

This application is a continuation in part of U.S. application Ser. No.14/929,625, filed on Nov. 2, 2015, which is a continuation in part ofInternational Application PCT/US2014/036315, with an internationalfiling date of May 1, 2014, which claims priority to and the benefit ofU.S. Provisional Patent Application No. 61/818,627, filed May 2, 2013entitled “A CATHETER COLLECTION AND DRAINAGE DEVICE AND SYSTEM”, whereinsaid patent applications are incorporated herein by reference in theirentireties.

FIELD AND BACKGROUND OF THE INVENTION

The invention relates generally to a device and system for bodily wastecollection and drainage.

Currently, patients dealing with urinary incontinence and that arecatheter users tend to fall into one the following categories: 1)patients that use self-intermittent catheters where no urine collectionor drainage bags are necessary; 2) patients with indwelling or Foleycatheters who rely on some type of drainage/urine collection bag; and 3)male patients who wear an external or condom catheter (or sheathcatheter) that also require a urine drainage bag or collection system.Patients, male or female, that have to rely on some form of collectionor drainage bag are faced with a number of challenges such asportability of such a collection bag without creating wardrobe issuesand ease of drainage of the collection bag, especially in publicrestrooms, just to name a few.

The storage or collection bags currently provided usually attach to thebody, customarily to the leg or thigh, by one or two straps, and isconnected to either the indwelling catheter or the sheath/condomcatheter (or catheter tip) portion by a plastic tube. One challenge isthat, as urine collects in the storage bag, its increased weightsometimes causes the connections to disengage or the condom/internalcatheter to be pulled loose from the male penis or from the female'surethra. Another challenge is that there are various sources ofpotential leakage, i.e., at any of the connection points between thecollection bag and an interconnection tube between the bag and theindwelling catheter or seal leaks in the collection bag due to apressure spike. The result being frequent spillage, leaking, soiling,and embarrassment to the user. Another challenge is that this ungainlyarrangement is a barrier to many normal activities, such as running,aerobics, and light physical work.

Further problems relate to the emptying of the bag of urine, as wellwith the attachment of the storage bag to the leg or thigh. Either theuser has to undress in order to empty the bag, or he has to weartrousers loosely-fitting enough to allow a user to roll up the trouserleg to get at it. Both methods are cumbersome and require the user totake much longer to use a toilet or urinal than is normal. Moreover, ifa man has to drain the storage bag in a public urinal, he is faced withan embarrassing situation. Another disadvantage is that there isinsufficient support for the storage or collection bag beyond the strapsfitted around the leg, which are both tight and uncomfortable yetinsecure (i.e., the straps tended to restrict blood circulation yetcould not always prevent the storage unit from slipping down the leg).Also, the storage bag prevents the user from wearing ordinary,closely-fitted street clothes, because the collection bag outline couldshow through and because the trouser leg could not be rolled up highenough to allow the user to access the bag. The drain valve on thesestorage bags also presents problems, whether the pull-out plug or thescrew-off cap. Men with shaky or arthritic hands or with neurologicpathologies (MS, Parkinson's disease, stroke, etc.) might havedifficulty replacing a plug or screwing a cap off and on. Some usersalso tended to get urine on their hands while draining the device.

Further, the disabled have particular difficulty in handling suchcollection bags. The problems of the various types of drainage cathetersare so great that some patients are unable to cope with them. Hence, inthese instances the only alternative is to wear bulky and embarrassingadult diapers or to refuse to go out in public at all. For all thesereasons, the urine-incontinent man or woman is often severelyhandicapped in both his economic and social life.

In one prior art device, Cawood discloses in U.S. Pat. No. 4,449,971 anabdominally located urine collection bag that is connected to a catheterprotruding up from the patient's urethra (in this case, the patient'spenis), such that the patient's urine needs to travel upwards againstgravity to be deposited in the abdominally located collection bag. Astaught therein, this collection bag system depends on the patient'sbladder detrusor muscle tone and intraperitoneal pressures exerted uponthe bladder of the catheterized ambulatory patient so as to cause urineto flow from the bladder to a level as high as 10 centimeters or moreabove the distal tip of the catheter within the patient. The collectionbag is carried by a waistband or belt and is worn over the patient'sabdomen and the bag disclosed in the Cawood patent has a shortvalve-equipped drain tube that extends downwardly from the bag when thecontents are to be drained and that may be folded upwardly and insertedinto a pocket provided by the bag when the drain tube is not in use. Achallenge with the Cawood system is that not all patients havesufficient bladder strength to force their urine up against gravity toan abdominally located collection bag (especially if a patient has aneurogenic bladder, which provides minimal to no bladder contractions).Further, this collection bag will require more loose fitting clothes toaccommodate the device and can create leakage issues if the user has tobend over at the waist just to pick something up.

Cawood in U.S. Pat. No. 6,471,680 also discloses an abdominally-worncollection bag that includes a long coiled extension tube connected tothe drain tube and drain tube connector to allow the patient to drainthe urine contents directly into a toilet bowl as shown in the '680patent. The extension tube has the challenge of having to be uncoiledand then re-coiled and strapped into the front face of this collectionbag when trying to empty the urine bag. This requires manual dexterityin managing the tube, partially undressing to manage the long tube andsome hygienic challenges in cleaning the tube after each use andensuring that it is completely empty before recoiling.

Therefore, there is a need for a urine or body waste collection anddrainage device and system that is simple to use and facilitates ease ofdrainage for the mobile and active patient without all of thecomplexities of the aforementioned prior art devices.

SUMMARY OF THE INVENTION

Various embodiments of a bodily waste collection and drainage device andsystem described herein provide advantages over the prior art such asease of use, ease of drainage or disposal of contents, accommodates tothe user's body and clothing, and longer use due to robust supportsystem. It would further be advantageous to have a collection anddrainage device for both men and women that is easy to use and moresanitary then current options available on the market.

In one example embodiment, a bodily waste collection and drainage systemis comprised of a collection bag, a support band or strap adapted tosupport the bag on the user, an inlet configured to be coupled to acatheter of a user and an outlet having a drainage tube member passingthere through for ease of drainage or emptying of the collection bag.The drainage tube member includes a valve for turning on or off theoutflow of bodily waste from the collection bag. In a relatedembodiment, the collection system is configurable for use in colostomyapplications or for other drainage applications for the human body.

In another example embodiment, a catheter device accessory assembly forurine collection of a patient is provided that includes a urinecollection vessel having an upper portion and a lower portion and aninlet port disposed on the urine collection vessel and configured to becoupled to a connector, the connector adapted to be connected to acatheter device. The device accessory also includes an outlet portdisposed on the upper portion of the urine collection vessel anddisposed separate and above the inlet port, the outlet port having anexternal side and an internal side. The device accessory also includes adrainage tube assembly comprising an external tube portion and aninternal tube portion, the external tube portion coupled to the externalside of the outlet port and adapted to extend away from the collectionvessel for drainage, the internal tube portion coupled to the internalside of the outlet port and adapted to extend from the outlet port andinternally into the lower portion of the collection vessel, a distal endof the internal tube portion in operative contact with a floor or bottomof the collection vessel, wherein the internal tube has at least onehole in a sidewall of the tube spaced from the distal end of theinternal tube portion. In addition, the collection vessel is configuredto be emptied through said drainage tube assembly upon initialcompression by the patient of the lower portion of the collectionvessel, thereby commencing a siphoning action. In a related embodiment,the urine collection vessel is adapted to be emptied through thedrainage tube and with compression by the patient when in a standingposition. In yet another related embodiment, a waistband attachmentassembly is included which is adapted to support the collection vesselon a user's body such that the inlet port is adjacent a proximal end ofa catheter located in a patient's urethra. The device accessory furtherincludes a leg band member configured to secure the collection vessel toa patient's leg and includes a spacing gap member located between thewaistband assembly and the upper portion of the collection vessel, thespacing gap configured to house the non-extended external tube portion.

In yet another example embodiment, a catheter accessory device forcollecting urine from a patient includes a urine collection vesselhaving an upper and lower portions and configured to be supported by thepatient's waist or leg and an inlet port coupled to the urine collectionvessel the inlet port having a connector coupled to a catheter. Theaccessory device also includes an outlet port disposed in the upperportion of and coupled to the urine collection vessel, the outlet portcoupled to a drainage tube member that is adapted to extend above theinlet port and away from the collection vessel, an internal portion ofthe drainage tube member extending to a bottom of the urine collectionvessel and an external portion of the drainage tube member comprising avalve for selectively draining the urine collection vessel. Theaccessory device also includes a drain valve coupled to the bottom ofthe urine collection vessel and coupled at another end with the internalportion of the drainage tube member, the internal portion of thedrainage tube being disposed in an upright configuration from the drainvalve and including at least one hole in a sidewall near the drainvalve. The urine collection vessel is also adapted to be emptied throughthe drainage tube member when the patient is in a standing position byinitially compressing the vessel until a siphoning action commences.

In yet another related embodiment, a front panel of the collectionvessel of the catheter device assembly is configured to be compressedagainst a stiffened rear panel of the collection vessel to improvecollection vessel drainage. In this example embodiment, the stiffenedrear panel is either a thicker rear collection vessel or arigid/semi-rigid backing plate or panel disposed next to the rear panelof the collection vessel.

In yet another example embodiment, a bodily fluid collection system foruse by a patient including a collection vessel configured to have aninlet port and an outlet port, the inlet port disposed proximate to apatient's drainage orifice when the collection system is in use, whereindrainage from the orifice occurs gravitationally. The system alsoincludes a bodily conduit member configured to be coupled to said inletport and coupled to the patient's drainage orifice and a drainageconduit member configured to be coupled to the outlet port and adaptedto extend from the collection vessel for drainage of the collectionvessel, wherein a portion of the drainage conduit member extendsinternally into the collection vessel below the inlet port and wherein adistal end of said drainage conduit member is in operative contact witha floor or bottom of the collection vessel, the drainage conduit memberhaving at least one hole in a sidewall of the tube spaced from thedistal end of said drainage conduit member; wherein said collectionvessel is configured to be emptied through said drainage conduit memberupon initial compression by the patient of the lower portion of thecollection vessel, thereby commencing a siphoning action.

The invention now will be described more fully hereinafter withreference to the accompanying drawings, which are intended to be read inconjunction with both this summary, the detailed description and anypreferred and/or particular embodiments specifically discussed orotherwise disclosed. This invention may, however, be embodied in manydifferent forms and should not be construed as limited to theembodiments set forth herein; rather, these embodiments are provided byway of illustration only and so that this disclosure will be thorough,complete and will fully convey the full scope of the invention to thoseskilled in the art.

DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is a view of a prior art urine collection and drainage device.

FIG. 2A is a view of an example embodiment of a urine or bodily wastecollection system according to the teachings herein.

FIG. 2B is a view of an example embodiment of a bodily waste collectionand drainage system in use by a male patient according to teachingsherein.

FIG. 2C is another example embodiment of a bodily waste collection anddrainage assembly according to the teachings herein.

FIGS. 3A-3B are views of a waistband accessory for a bodily wastecollection device as taught herein.

FIG. 4 illustrates a side view of a waste collection bag as taughtherein.

FIG. 5 illustrates a front view of another waste collection bag astaught herein.

FIGS. 6A and 6B illustrate front and side views of another bodily wastecollection assembly as taught herein; and

FIG. 7 illustrates a front view of yet another bodily waste collectionassembly as taught herein.

DETAILED DESCRIPTION OF THE INVENTION

Following below are more detailed descriptions of various embodiments ofthe invention described herein. In particular, the various embodimentsdisclosed herein describe a urine collection and drainage device forpatients that prefer to drain their urine collection bag while in astanding position. It should be appreciated that various aspects of thesubject matter introduced above and discussed in greater detail belowmay be implemented in any of numerous ways, as the subject matter is notlimited to any particular manner of implementation. Examples of specificimplementations and applications are provided primarily for illustrativepurposes.

Referring to FIG. 1, there is a shown a prior art urine collection anddrainage device 20 on a patient's leg 10. Device 20 includes acollection bag 21, an inlet 22, a drain outlet 24 and a pair of straps,upper 26 and lower strap 28. A catheter (not shown) would normally beinserted into the patient's bladder through the urethra, which is thencoupled to inlet 22. One disadvantage of this device is that collectionbag 21 needs to be emptied from the lower drain outlet 24 requiring thepatient to disrobe or pull his pants down in order to reach and activatedrain outlet 24. This is more of a challenge if the patient is in awheelchair or uses a cane or walker.

Referring now to FIGS. 2A-2C, there are described various embodiments ofa bodily waste collection and drainage system and device thatfacilitates emptying or drainage from a standing position of a user orpatient. Even if the patient is in a wheelchair or confined to a bed,the bodily waste collection system described herein still allows apatient to conveniently empty the collection bag into a bedpan or it canbe used to collect urine samples conveniently from the patient.

Referring particularly to FIGS. 2A and 2B, there are shown views of anexample embodiment of a bodily waste collection and drainage system 200for use by a male patient 100 (detached and attached) according toteachings herein. In a related embodiment, system 200 is configured foruse for with a female patient and the embedded catheter is configuredfor connection with the collection bag (such as in FIG. 2C). In thisexample embodiment, system 200 includes a collection bag 210, an inlet222, an outlet 224 and a bottom drain 226. Inlet 222 is coupled to aconnector 223 which is coupled to a catheter 230 that is inserted into apatient's urethra (genital area 112) for drainage of urine collected bybag 210. A urine (or other bodily fluid) exit tube 225, having a tipvalve 225A, is coupled to outlet 224 for draining or emptying bag 210through an upper portion of bag 210. Tube 225 has a customizable lengthwith an interior diameter (ID) of about, but not limited to, 0.25inches. In this example embodiment, tube 225 is comprised of an internalportion 225B (inside bag 210) and an external portion 225C (spanningoutside bag 210), with the internal portion 225B having a series ofholes 225D (optional) to facilitate drainage and manage internalpressure. In various embodiments, tube 225 is formed from one or moremembers. Valve 225A can be a twist on/off valve, a push button valve,ball valve, a unidirectional valve, a duck bill or any other valvedevice that allows for drainage of the collection bag with asubstantially immediate shut-off. In a related embodiment, the valve ispressure activated and opens when pressure exerted by the patient on thebag (when trying to empty the bag) exceeds the valve's pressurethreshold. In this embodiment, the valve's pressure threshold isconfigured to be high enough to avoid leakage if incidental orinadvertent pressure is placed on the collection bag.

In this example embodiment, exit tube 225 spans a longitudinal length ofbag 210 towards the bottom of the bag to assist in the emptying ordraining of the bag. Once the user pulls or extends exit tube 225 andpoints it towards the toilet (or the urinal if standing up or the bedpanif the patient is in bed or in a wheelchair) and actuates valve 225A,pressure is applied to the bag by the user and then urine or bodilywaste is dispelled through tube 225. Waste collection assembly 200optionally includes a waistband or holster accessory 240 for supportingbag 210 (at loop or holes 212 and 214) and optionally at least one legstrap 250 for strapping bag 210 to a patient's leg. In this exampleembodiment, bag 210 is formed in a triangular shape to accommodate theuser's leg and body contour.

Note that a proximal end of catheter 230 (coming out of patient'surethra) is disposed level to or substantially level to inlet 222 andconnector 223 such that a natural drainage level (taking advantage ofgravity) is used for the patient's convenience, hence not requiringexcessive bladder muscles to push the urine out. Another advantage tothis design is that the patient controls the drainage and the emptyingof the collection bag versus being forced to empty the entire contentsall at once with other prior art devices. The ability to controlemptying of the collection bag is useful when circumstances may notpermit the patient to empty the entire contents all at once. Anotheradvantage to collection system 200 is that it has two bodily waste exits(tube 225 and drain 226) as compared to prior art systems that just haveone exit, just in case one collection bag drainage option fails.

Yet another advantage of the collection bag systems disclosed herein isthat collection bag 210 is configured to be positioned along the side ofone leg near the waist to be more conducive to the contour of thepatient's body and urethral drainage into the bag. In a relatedembodiment, collection bag 210 is configured to be located in the insideof the patient's leg to help with concealment, such as when a femalepatient decides to wear a skirt or a male patient prefers to have thecollection bags (with associated connectors/connections) on the insideportion of one leg. In yet another embodiment, system 200 isconfigurable to have two collection bags on both legs for longer usewhen traveling or when it is not convenient to empty for a number ofhours.

Referring now to FIG. 2C, there is shown another example embodiment of abodily waste collection and drainage assembly 200A according to theteachings herein. System 200A includes a standard rectangular collectionbag 210A, with an inlet 222A, an outlet 224A located at the medialaspect of the bag and a bottom drain 226A. Inlet 222A is coupled to aconnector 223A which is coupled to a catheter 230 that is inserted intoa patient's urethra for drainage of urine collected by bag 210A. An exittube 225A, having a tip valve 225B, is coupled to outlet 224A fordraining or emptying bag 210A through an upper portion of bag 210A. Oncethe user pulls or extends exit tube 225A and points it towards thetoilet (or the urinal if also using it in a standing position) andactuates valve 225A, mild pressure or compression is applied to bag 210Aand then urine or waste is dispelled through tube 225A. Once the bag isemptied to the patient's satisfaction, valve 225A is closed and tube225A is returned to inside the patient's clothing. In a relatedembodiment, system 200 or 200A or 600 are configurable to include a clipor holder to hold tube 225 securely to bag 210 after use.

In a related embodiment, the collection bag is configured to have anexit tube comprised of an internal portion member that resides insidebag 210 and an external portion member that extends away from thecollection bag and is used by the patient for regular bag drainage.Advantages to this embodiment include hygiene within the bag ismaintained as the internal portion member of the exit tube stays withinthe bag while the external portion may be changed by the patient for anyreason. In a related embodiment, the internal portion member ispermanently coupled to an outlet port connector that in turn is coupledto an interchangeable external portion tube member.

In a yet another example embodiment, bag 210 is configured to have aninlet port and outlet port on the same side of bag or vessel 210 tofacilitate flexibility in locating vessel 210 proximate to a patient'sbodily fluid drainage orifice (such as a patient's urethra; or abdomenfor abdominal drainage or near buttocks for fecal drainage). In thisexample embodiment, the outlet port is connected to an exit tube memberthat is extendible through a patient's clothing (pants, shirt, skirt,etc.) thereby facilitating easy drainage without completely disrobing.

In a related embodiment, the collection bag is configurable to onlyinclude the upper exit tube without the need for the lower drain tube ordrain outlet. This is especially useful where the patient needs a urinecollection system with a smaller form factor or wishes to dispose of theunit after it is full. System 200 is configurable for other uses such asa colostomy bag that can be emptied if necessary or used in connectionwith other drain tubes for bodily fluids wherein the fluid drips ordrains out with or without gravitational forces.

Referring now to FIGS. 3A-3B, there is a view of a waistband member orassembly 240 for a collection device as taught herein. In particular,member 240 includes a band 242 that includes a fastener assembly 244 atboth ends. Fastener assembly 244 includes, but is not limited to, a hookand loop (Velcro®) arrangement, a snap button, and a button and buttonhole. Waistband member 240 includes connection members 246 forsupporting bags 210, 210A, 410, 510, and 610.

In a related embodiment, the collection bag is supported in the pelvicarea (near the urethra) by providing a spandex-type leg cuff, sleeve orband member (which can also be in the form of a band with a hook andloop or simply a hook fastener, depending on the band material chosen,that is wrapped around the appendage) that is pulled up to the thigh andthat has an additional external pocket/sleeve that allows the patient toslip the collection bag down into it. The spandex cuff or sleeve or bandmember (or other elastic-type material) can have a side slit toaccommodate the Foley connection (from the catheter in urethra) and alower slit to accommodate the bottom drain. In an alternativeembodiment, the sleeve (or cuff or band) is on the inside of the leg sothat it is between the legs instead of on the side of the leg. The sidesleeve/pocket can also be large enough to accommodate a plate member(plastic or other rigid/semi-rigid) that serves as a back plate to thebag to allow the user to press the collection bag or vessel against itfor additional leverage. Another advantage to this feature is that ininstances where patients have difficulty applying pressure to the bag,the sleeve or cuff or band member can act as the source for producingback pressure within the collection bag as it fills with urine. Thelevel of back pressure, which would be advantageous for bag drainage,can be determined by the denier and compliance of the sleeve or cuff.

Referring now to FIG. 4, there is shown a side view of an example urinecollection bag assembly 400 according to the teachings herein. Bagassembly 400 includes a bag portion 410, with a belt loop assembly 440,and a backing plate 416. Belt loop assembly 440 includes a belt loopmember 442 and a rear loop support 443, both of which support bag 410near the lower pelvic (or genital) area of a patient. Backing plate 416,in this example embodiment, is either rigid or semi-rigid to provide asurface against a backside 413 of bag 410 to assist the user (duringcompression) in emptying or draining the bag, as pressing the bag onlyagainst the user's leg during draining may be inefficient or timeconsuming. In one example embodiment, a waistband assembly used tosupport bag 410 near the patient's lower pelvic area is equipped withbacking plate 416. In a related embodiment, bag 410 includes a thickerlayer of polyolefin (or PTFE or ePTFE), polyethelyene, polypropylenematerial or the like to assist in compression of bag 410 by the patient.In yet another related embodiment, backing plate 416 is substituted witha spun polymer sheet fabric or felt-like surface to promote airflowbetween the leg skin and collection bag 410. In various embodiments, bag410 has a volume of about 400 ml-800 ml and a configuration that istapered in the direction away from belt loop assembly 440.

Referring now to FIG. 5, there is shown a front view of another examplecollection assembly 500 which includes a bag portion 510, with a portionof a belt holding assembly 540 (and retaining buttons 541) and a lowerretaining leg strap 542. Similar to collection assembly 200, assembly500 includes an inlet 522 with associated connector 523 to connect to aFoley catheter, an outlet 524 with a catheter 525 located there through.Catheter 525 is comprised of an internal portion 525B (with optionalholes 525D), an external portion 525C and an end portion/cap with avalve 525A. In this example embodiment, inlet 522 is equipped with aunidirectional flow valve (or duck valve) in the rear (or inside of bag)to prevent bodily waste or urine from flowing retrograde back towardsthe patient's catheter and thus the patient's bladder.

Referring now to FIGS. 6A and 6B, there are shown front and side viewsof another example embodiment of a bodily waste collection and drainagesystem 600 for use by a male patient according to teachings herein. In arelated embodiment, system 600 is configurable for use by a femalepatient and the embedded catheter is configured for connection with thecollection bag. In this example embodiment, system 600 includes acollection bag 610, a belt loop assembly portion 640 with a spacermember 650, which provides some distance between collection bag 610 andloop assembly 640, thereby allowing bag 610 to be suspended near thepatient's lower pelvic area (close to a urethral catheter). In thisexample embodiment, seal lines are formed between various sections tostrengthen the assembly while creating some space for hygiene for thepatient. For example, a seal line 641 is located between belt loopassembly 640 and spacer member 650. A seal line 651 is located betweenspacer member 650 and bag 610. A side view of assembly 600 (FIG. 6B) islined up with the front view and shows loop 640, spacer member 650, afront 611 of bag 610 and a rear 613 of bag 610.

In this example embodiment, bag 610 includes an ePTFE (or other suchmaterial which acts as a one way vent) vent 615, an inlet 622; an outlet624 and a bottom drain 626 with a cleanout valve. Inlet 622 is coupledto a connector 623 which is coupled to a catheter 630 (not shown) thatis inserted into a patient's urethra for drainage of urine collected bybag 610. A urine (or other bodily fluid) exit tube 625, having a tipvalve 625A, is coupled to outlet 624 for draining or emptying bag 610through an upper portion of bag 610. In this embodiment, catheter 625 iscomprised of an internal portion 625B (with optional holes 625D), anexternal portion 625C, an outer diameter tube 625E, and an endportion/cap with a valve 625A. Valve 625A can be a twist on/off valve; apush button valve; ball valve, unidirectional valve, duck bill valve orany other valve device that allows for drainage of the collection bagwith a substantially immediate shut-off. In a related embodiment, thevalve is pressure activated and opens when pressure exerted by thepatient on the bag (when trying to empty the bag) exceeds the valve'spressure threshold. In this embodiment, the valve's pressure thresholdis configured to be high enough to avoid incidental or inadvertentoutflow due to pressure placed on the collection bag.

In this example embodiment, exit tube 625 spans a longitudinal length625B of bag 610 towards the bottom of the bag to assist in the emptyingor draining of the bag. Once the user pulls or extends exit tube 625 andpoints it towards the toilet (or the urinal if also standing up or thebedpan if the patient is in bed or in a wheelchair) and actuates valve625A, pressure is applied to the bag by the user and then urine orbodily waste is dispelled through tube 625. Waste collection assembly600 optionally includes a waistband or holster accessory that couples tobelt loop assembly 640 for supporting bag 610 and at least one leg strap650 for strapping bag 610 to a patient's leg. In this exampleembodiment, bag 610 is formed in a triangular or upside flask shape toaccommodate the user's leg and body contour.

In use, the patient's indwelling catheter is disposed level orsubstantially level to inlet 622 and connector 623 such that naturaldrainage (e.g., gravity) is used for the patient's convenience, hencenot requiring excessive bladder muscles to push the urine out (or up toa bag as in the prior art). Another advantage to this design is that thepatient controls the drainage and the emptying of the collection bagversus being forced to empty the entire contents all at once with otherprior art devices. The ability to control emptying of the collection bagis useful when circumstances may not permit the patient the empty theentire contents all at once. Other advantages to this collection systemare similar to that described above. Collection bag 610 also includes aset of pleats (baffles) 618 to facilitate drainage. Catheter tube device625, in various example embodiments is customizable in length, is formedfrom various materials including a corrugated or ribbed material and hasan internal diameter (ID) large enough (for example 0.25 inches) tofacilitate drainage and keep internal pressure to a minimum.

An example of the components and materials used in the variouscollection systems describe herein include:

Mfgr. And PN Description Qosina: 80041 p.172 Tube End Drain Valve, BagCleanout and Drain Line Qosina: 94617 p.167 Urinary Connector, 1-way,Foley Connection Qosina: DEPH Free PVC Bag Drain Tube ¼″ × ⅜″ Class IVQosina: DEPH Free PVC Bag Clean Out Tube 0.280″ × Class IV 0.400′Elastic Waist Band w/Velcro tab, 1.5″ × 30″ Elastic Leg Strap w/Velcrotab, 1.0″ × 30″ Bag, Back, 8 mil Polyolefin Thicker bag backing sheetBag Front, 3 mil Polyolefin Thinner bag face sheet, Leg Strap tab, 8 milHeat bonded to receive polyolefin sheet waistband

The various collection bags described herein are made from any one of,or a combination of, materials: PTFE, expanded PTFE, and PTFEcomposites, which provide airflow and liquid resistance for ventedcontainers. When integrated into a package design, ePTFE allows for theinflow of gases such as air without allowing liquid to penetrate theventing membrane and subsequently permeate out of the collection bag asinternal pressure builds. When liquid penetrates other porous material,airflow stops. This phenomenon is referred to as “wetting out”. Ordinarymembranes that simply allow initial airflow will clog quickly,prohibiting consistent airflow and will often leak—especially when acontainer is in an upside down position during use. Packaging vents,such as vent 615, allow consistent airflow, even after liquid contact.When liquids are sprayed or dispensed, a vacuum is created within aclosed system. These packaging vents allow the package to breathe byequalizing pressure. This simple closure vent solution helps to assurethat containers maintain their shape and do not leak while liquids arebeing dispensed.

Referring now to FIG. 7, there is shown a front view of yet anotherexample embodiment of a bodily waste collection and drainage system 700for use by a male patient according to teachings herein. In a relatedembodiment, system 700 is configurable for use by a female patient andan embedded catheter is configured for connection with the collectionbag. In this example embodiment, system 700 includes a collection bag710, a belt loop assembly portion 740 with a fastener 742 with a spacermember 750, which provides some distance between collection bag 710 andloop assembly 740, thereby allowing bag 710 to be suspended near thepatient's lower pelvic area (close to a urethral catheter). In thisexample embodiment, seal lines are formed between various sections tostrengthen the assembly while creating some space for hygiene for thepatient. For example, a seal line 741 is located between belt loopassembly 740 and spacer member 750, while another seal line 751 islocated between spacer member 750 and bag 710.

In this example embodiment, bag 710 includes (optionally an ePTFE ventor other such material which acts as a one way vent) an inlet 722 and aduck bill or unidirectional flow valve 722A; an outlet 724, outlet weld724A and a connector 724B; and a bottom drain joint 726A with a cleanoutvalve 726. Inlet 722 (which may also have a weld connected to the sideof the bag for stability) is coupled to a connector 723 which is coupledto a catheter 730 (not shown) that is inserted into a patient's urethrafor drainage of urine collected by bag 710. A urine (or other bodilyfluid) exit tube 725, having a tip valve 725A, is coupled to outlet 724for draining or emptying bag 710 through an upper portion of bag 710. Inthis embodiment, catheter 725 is comprised of an internal portion 725B(with optional one or two infeed holes 725D), an external portion 725C,an outer diameter tube 725E, and an end portion/cap with a valve 725A.Valve 725A can be a twist on/off valve; a push button valve; ball valve,unidirectional valve, duck bill valve or any other valve device thatallows for drainage of the collection bag with a substantially immediateshut-off. In a related embodiment, the valve is pressure activated andopens when pressure exerted by the patient on the bag (when trying toempty the bag) exceeds the valve's pressure threshold. In thisembodiment, the valve's pressure threshold is configured to be highenough to avoid incidental or inadvertent outflow due to pressure placedon the collection bag.

An example of the components and materials used in the variouscollection systems describe herein include:

Description Material State Narrow Fabric Strap- White Plush Latex FreeWaist (Skin Contact) State Narrow Fabric Strap- White Plush Latex FreeLeg (Skin Contact) Velcro PSA Hook Velcro, Nylon with RF Adhesive LegStrap w/1.5 × 0.375″ Slit PVC, (DEHP Free) Input Port (Tube) for MandrelPVC tube (DEHP Free) (Urine Contact) Duckbill Valve (Urine PVC valve,Seal on Edge Contact) Input Connector Urinary Connector PC Output Port(Tube) for PVC Tube (DEHP Free) Top/Bottom Mandrel w/¼″ Drain HolesOutput Port (Tube) for PVC Tube (DEHP Free) Cushion Output PortConnector for HDPE Tube Tube Drainage Valve PVC Tube End Drain Valve,Twist Control Tactile Cushion (Skin Drain Tube Cushion Contact) BackSheet 1 (Skin Contact) PVC, losy Sontara (DEHP Free) Back Sheet 2 PVC(DEHP Free) Top Sheet PVC (DEHP free)

In this example embodiment, exit tube 725 spans an almost longitudinallength 725B of bag 710 towards the bottom of the bag (including anupright section attached to the drain valve with holes 725D tofacilitate siphoning of the fluids) to assist in the emptying ordraining of the bag. In this configuration, internal tube 725B is fixedto the apex or bottom of the vessel on one end and is affixed at theother end the outlet connector, thereby avoiding kinking of the tube orblocking of infeed holes 725D (holes are about 0.25 inches in diameter).One of the advantages of this configuration is that the urine or bodilyfluid pressure builds at the bottom of the vessel as the bag fills andtherefore holes 725D are located at the highest pressure points withinthe bag. Once the user applies initial compression to empty the bag orvessel, hydraulic pressure will quickly build up within tube 725B at thebottom so that the fluid flows over the peak curve in the drain tubeportion external to the bag and will start emptying the bagautomatically and without further compression. In other prior artconfigurations, the use of Y or T connectors to connect the inlet andoutlet to the same internal drain tube or to connect to only one port,by which both the inlet and outlet tubes are connected, althougharguably cost effective due to less parts being used in the device, theconnectors and shared inlet/exit tubes actually lower the pressure atthe bottom of the collection bag making it more difficult for the userto empty the bag contents and to try to initiate the siphoning oremptying action. In other prior art configurations, only using interiortube or the drainage tube and valve at the bottom of the bag (each ofwhich may not be not secure and subject to movement or kinking) makesdraining the bag through the upper drainage tube dependent on theinterior diameter of the drainage tube opening and the expectation ofminimal movement of the unsecured tube end within the bag or collectionvessel.

Once the user pulls or extends exit tube 725 and points it towards thetoilet (or the urinal if also standing up or the bedpan if the patientis in bed or in a wheelchair) and actuates valve 725A, pressure isinitially applied to the bag by the user and then urine or bodily wasteis expelled through tube 725 once the siphoning action commences (afterwhich the user no longer needs to exert any pressure as the bag emptiesitself). In this example embodiment, the combination of the uprightconfiguration of the tube near the drain valve along with the infeedholes on the sidewall facilitate the creation of the siphoning action toempty the vessel. Waste collection assembly 700 optionally includes awaistband or holster accessory that couples to belt loop assembly 740for supporting bag 710 and at least one leg strap 750 for strapping bag710 to a patient's leg. In this example embodiment, bag 710 is formed ina triangular or upside flask (or chevron) shape to accommodate theuser's leg and body contour as well as to concentrate the bodily fluid(and pressure) closer to the drain tube and infeed holes 725D.

In use, the patient's indwelling catheter is disposed level orsubstantially level to inlet 722 and connector 723 such that naturaldrainage (e.g., gravity) is used for the patient's convenience, hencenot requiring excessive bladder muscles to push the urine out (or up toa waist bag as in the prior art). Another advantage to this design isthat the patient controls the drainage and the emptying of thecollection bag versus being forced to empty the entire contents all atonce with other prior art devices. The ability to control emptying ofthe collection bag is useful when circumstances may not permit thepatient to empty the entire contents all at once. Other advantages tothis collection system are similar to that described above. Cathetertube device 725, in various example embodiments is customizable inlength, is formed from various materials and has an internal diameter(ID) large enough (for example 0.25 inches) to facilitate drainage andkeep internal pressure to a minimum. Various embodiments describedherein are operable with different types of catheters including, but notnecessarily limited to, Foley and condom or uri-sheath catheters.

In another example embodiment, a bodily fluid collection system for apatient is provided that includes a bodily fluid collection vesselhaving an upper portion and a bottom portion and an inlet port disposedon said fluid collection vessel. The fluid collection system alsoincludes a drain valve coupled to the bottom portion of the fluidcollection vessel and is adapted for selectively draining contents ofthe collection vessel upon actuation of the drain valve. The fluidcollection system further includes a waistband attachment assemblyadapted to support said fluid collection vessel on a user's body and onthe user's leg. The waistband attachment assembly is configured tosupport the collection vessel on the user's body such that the inletport is adjacent an end of a catheter located away from a patient'surethra. The waistband assembly further includes a leg band memberconfigured to secure said collection vessel to a patient's leg. Inrelated embodiments, waistband attachment assembly includes at least oneloop such that a user can pass a waist-belt through the loop to supportthe collection vessel or includes a waistband with a fastener assemblyat least at one end, wherein the fastener assembly includes one of ahook and loop arrangement, a snap button, a button and button hole.

In a related example embodiment, the inlet port is configured to beconnected to a catheter device and the collection system furtherincludes a spacing gap member located between the waistband assembly andthe upper portion of the collection vessel, the spacing gap configuredto house an optional external tube portion. The collection systemfurther includes a drainage tube assembly coupled to the drain valve andis adapted to extend away from the collection vessel for drainage. Inthis example embodiment, the drain valve member for selectively drainingsaid fluid collection vessel is selected from the group consisting of atwist on/off valve, a push button valve, a ball valve, a unidirectionalvalve, and a duck bill valve.

In yet another related embodiment, the collection vessel is formed in ashape selected from the group consisting of a chevron, an upside downtriangle, an ellipse, and a teardrop. The collection vessel isconfigured to be compressed against a stiff rear or back panel coupledto and protruding down from the waistband attachment assembly, whereinthe stiff back panel contacts the user's leg. In a related embodiment, afront panel of said collection vessel is configured to be compressedagainst an equally sized stiffened rear panel of said collection vesselto improve collection vessel drainage of contents within said collectionvessel. In yet another related embodiment, the collection vesselincludes one of a vent on an upper portion of the vessel, an inlet portwith a unidirectional flow valve to prevent fluids from flowing outthrough the inlet port and at least one baffle within the collectionvessel adapted for ease of drainage.

In yet another example embodiment, a catheter device accessory assemblyfor urine collection of a patient includes a urine collection vesselhaving an upper portion and a bottom portion and an inlet port disposedon said urine collection vessel and configured to be coupled to acatheter device. The device accessory assembly further includes a drainvalve coupled to the bottom portion of the urine collection vessel andis adapted for selectively draining contents of the collection vesselupon actuation of the drain valve. The assembly further includes a legattachment assembly adapted to support the collection vessel about auser's leg. In a related embodiment, the leg attachment assemblyincludes a pocket or pouch to support the collection vessel and the legattachment assembly is one of an expandable leg cuff, a leg brace and abandage configured to be wrapped around a user's leg.

The following patents and publications are herein incorporated byreference in their entireties: U.S. Pat. Nos. 5,002,541; 5,618,277;6,007,521; 7,160,276; 7,931,630 and 8,002,766.

While the various embodiments of the invention have been described abovein terms of specific embodiments, it is to be understood that theinvention is not limited to these disclosed embodiments. Upon readingthe teachings of this disclosure, many modifications and otherembodiments of the invention will come to mind of those skilled in theart to which this invention pertains, and which are intended to be andare covered by both this disclosure and the appended claims. It isindeed intended that the scope of the invention should be determined byproper interpretation and construction of the appended claims and theirlegal equivalents, as understood by those of skill in the art relyingupon the disclosure in this specification and the attached drawings.

What is claimed is:
 1. A bodily fluid collection system for a patientcomprising: a bodily fluid collection vessel having an upper portion anda bottom portion; an inlet port disposed on the upper portion of saidfluid collection vessel; a bodily waste exit tube coupled to an outletdisposed on the upper portion of said fluid collection vessel, the wasteexit tube having internal portion extending into the bottom portion ofsaid fluid collection vessel and having an external portion adapted toextend away from said fluid collection vessel, the external portionhaving a tip valve member thereon for selectively draining by thepatient said fluid collection vessel; and a waistband attachmentassembly configured to support said fluid collection vessel on thepatient's body at the waist with the fluid collection vessel disposeddirectly on the patient's leg.
 2. The collection system of claim 1,wherein the waistband attachment assembly is configured to support thecollection vessel on the patient's body such that said inlet port isadjacent an end of a catheter located away from a patient's urethra. 3.The collection system of claim 1, wherein the inlet port is configuredto be connected to a catheter device.
 4. The collection system of claim1, wherein said waistband assembly further comprises a leg band memberconfigured to secure said collection vessel to the patient's leg.
 5. Thecollection system claim 1, further comprising a spacing gap memberlocated between the waistband assembly and the upper portion of thecollection vessel, the spacing gap configured to house an optionalexternal tube portion.
 6. The collection system claim 1, furthercomprising a drainage tube assembly coupled to a drain valve and adaptedto extend away from said collection vessel for drainage, the drain valvecoupled to the bottom portion of the fluid collection vessel and adaptedfor selectively draining contents of the collection vessel uponactuation of the drain valve.
 7. The collection system of claim 1,wherein the collection vessel is formed in a shape selected from thegroup consisting of a chevron, an upside down triangle, an ellipse, anda teardrop.
 8. The collection system of claim 1, wherein the tip valvemember for selectively draining said fluid collection vessel is selectedfrom the group consisting of a twist on/off valve, a push button valve,a ball valve, a unidirectional valve, and a duck bill valve.
 9. Thecollection system of claim 1 wherein said collection vessel isconfigured to be compressed against a stiff rear or back panel coupledto and protruding down from the waistband attachment assembly, whereinthe stiff back panel is configured to directly contact the patient'sleg.
 10. The collection system of claim 1, wherein a front panel of saidcollection vessel is configured to be compressed against an equallysized stiffened rear panel of said collection vessel to improvecollection vessel drainage of contents within said collection vessel,wherein the rear panel is configured to directly contact the patient'sleg.
 11. The collection system of claim 1, wherein the collection vesselincludes one of a vent on an upper portion of the vessel, and at leastone baffle within the collection vessel adapted for ease of drainage.12. The collection system of claim 1, wherein the waistband attachmentassembly includes at least one loop such that the patient can pass awaist-belt through the loop to support the collection vessel.
 13. Thecollection system of claim 1, wherein the waistband attachment assemblyincludes a waistband with a fastener assembly at least at one end. 14.The collection system of claim 13, wherein the fastener assemblyincludes one of a hook and loop arrangement, a snap button, a button andbutton hole.
 15. A catheter device accessory assembly for urinecollection of a patient comprising: a urine collection vessel having anupper portion and a bottom portion; an inlet port disposed on said upperportion of said urine collection vessel and configured to be coupled toa catheter device; a bodily waste exit tube coupled to an outletdisposed on the upper portion of said urine collection vessel, the wasteexit tube having internal portion extending into the bottom portion ofsaid urine collection vessel and having an external portion adapted toextend away from said urine collection vessel, the external portionhaving a tip valve member for selectively draining by the patient saidurine collection vessel upon actuation of the tip valve member; and aleg attachment assembly configured to support said urine collectionvessel directly on the patient's leg.
 16. The catheter accessory deviceof claim 15, wherein the leg attachment assembly includes a pocket orpouch to support the collection vessel.
 17. The catheter accessorydevice of claim 15, wherein the leg attachment assembly is one of anexpandable leg cuff, a leg brace or a bandage configured to be wrappedaround the patient's leg.